ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00002479NCI T91-0136NU-T91-0136NCI-T91-0136ONCT00002479Tretinoin in Treating Patients With Mycosis Fungoides or Sezary SyndromePhase II Trial of Tretinoin (TRA) in Patients With Mycosis Fungoides/Sezary SyndromeNorthwestern UniversityOtherNational Cancer Institute (NCI)NIHYes
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have
any stage mycosis fungoides or Sezary syndrome.
OBJECTIVES: I. Determine the efficacy of tretinoin (TRA) in patients with mycosis
fungoides/Sezary syndrome. II. Evaluate the spectrum of toxicity of TRA in this patient
population.
OUTLINE: Nonrandomized study. Single-agent Chemotherapy. Tretinoin, All-trans-Retinoic Acid,
TRA, NSC-122758.
PROJECTED ACCRUAL: If 1 or more of the first 15 evaluable patients experience an objective
response, then 20 additional patients will be entered. It is anticipated that the accrual
rate will be 1-2 patients per month.
CompletedOctober 1991August 2002August 2002Phase 2InterventionalNoTreatmentLymphomaDrugtretinoin
DISEASE CHARACTERISTICS: Biopsy-proven mycosis fungoides/Sezary syndrome Stage I-IV disease
No CNS involvement At least 1 measurable lesion required (skin, lymph nodes, visceral
lesion, or peripheral blood counts)
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-3 Hematopoietic: WBC at
least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no more than 2.0
mg/dL Transaminases no more than 2 x normal Alkaline phosphatase no more than 2 x normal
Renal: Creatinine no more than 2.0 mg/dL Other: No active systemic infection No significant
organ failure uncontrolled with medication No pregnant or lactating women Effective
contraception required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic therapy
Chemotherapy: At least 4 weeks since prior topical chemotherapeutics or systemic therapy
Endocrine therapy: At least 4 weeks since prior topical (including steroid) therapy or
systemic therapy Radiotherapy: Not specified Surgery: Not specified
All18 YearsN/ANoTimothy M. Kuzel, MDStudy ChairRobert H. Lurie Cancer CenterRobert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicagoIllinois60611United StatesUnited StatesSiegel RS, Martone B, Guitart J, et al.: Phase II trial of all-TRA in the treatment of relapsed/refractory mycosis fungoides. 94(1 suppl): A423, 96a, 1999.May 2012November 1, 1999August 20, 2004August 23, 2004February 16, 2011February 16, 2011February 18, 2011May 17, 2012May 17, 2012May 30, 2012Sponsorstage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomaMycosesLymphomaMycosis FungoidesSezary SyndromeTretinoin